Teva Pharmaceutical Industries can add another “W” to its win column after being stuck in a stalemate between U.S. courts for the last several months. Earlier this week, the U.S. Supreme Court ruled that Israel-based Teva can continue to benefit from its patent of its multiple sclerosis drug Copaxone, putting a temporary stop to the growing threats from drug makers looking to market a generic rival.
The ruling follows a July 2013 U.S. Court of Appeals for the Federal Circuit decision in favor of the generic drug companies, which overturned a previous lower court ruling that was in Teva’s favor. As part of the 7-2 Supreme Court vote, the justices recommended that the U.S. Court of Appeals review the case, criticizing the Appeals court’s analysis of the patent, which it threw out in its 2013 decision, leaving Copaxone without patent protection. The current patent for Copaxone expires in September 2015.
Meanwhile, Teva has been working to switch patients to a new and patent-protected version of the blockbuster MS drug, which accounts for 50% of Teva’s profits. The new version of Copaxone has a stronger dosage and is taken less frequently.
While the Supreme Court decision buys Teva more time to convert patients to the new version, it doesn’t mean that there won’t ever be a generic form that comes to market. Two teams are currently developing generic versions of Copaxome, including Novatis AG’s Sandoz unit and Momenta Pharmaceuticals and Mylan Inc. and Natco Pharma. Had the companies already introduced their versions of the drug, they would have been liable for damages.
The decision may also mark a shift in current judicial procedures for the Appeals court, which holds greater latitude over lower court findings. Following its review of the case and ruling, the Supreme Court said that the Appeals court should defer to the federal district judge unless there is evidence of a clear error, noting that a district court judge who has presided over the entirety of a proceeding has more familiarity with the case compared to an Appeals court.